FDA Public Health Advisory: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings

FDA Public Health Advisory
Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings

http://www.fda.gov/cder/drug/advisory/transdermalpatch.htm

The FDA has been made aware of information about certain transdermal patches (medicated patches applied to the skin) that contain aluminum or other metals in the backing of the patches. Patches that contain metal can overheat during an MRI scan and cause skin burns in the immediate area of the patch.

Transdermal patches slowly deliver medicines through the skin. Some patches contain metal in the layer of the patch that is not in contact with the skin (the backing). The metal in the backing of these patches may not be visible. The labeling for most of the medicated patches that contain metal in the backing provides a warning to patients about the risk of burns if the patch is not removed before an MRI scan. However, not all transdermal patches that contain metal have this warning for patients in the labeling.

FDA is in the process of reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns to patients who wear the patches during an MRI scan.

Until this review is complete, FDA recommends that healthcare professionals referring patients to have an MRI scan identify those patients who are wearing a patch before the patients have the MRI scan. The healthcare professional should advise these patients about the procedures for removing and disposing of the patch before the MRI scan, and replacing the patch after the MRI scan. MRI facilities should follow published safe practice recommendations concerning patients who are wearing patches.1,2

Until this safety issue is resolved, FDA recommends that patients who use medicated patches (including nicotine patches) do the following:

Tell the doctor referring you for an MRI scan that you are using a patch and why you are using it (such as, for pain, smoking cessation, hormones)
Ask your doctor for guidance about removing and disposing of the patch before having an MRI scan and replacing it after the procedure.
Tell the MRI facility that you are using a patch. You should do this when making your appointment and during the health history questions you are asked when you arrive for your appointment.
The FDA urges health care professionals and patients to report possible cases of skin burns while wearing patches during an MRI to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html.

(1) Kanal, et. al, “ACR Guidance Document for Safe MR Practices: 2007,” AJR 2007; 188:1–27.
(2) Guidelines for Screening Patients For MR Procedures and Individuals for the MR Environment, Institute for Magnetic Resonance Safety, Education, and Research, www.imrser.org, 2009.